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A Study to Assess Adverse Events and Change in Disease State in Adult Participants Being Treated With Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04750213
Collaborator
(none)
60
Enrollment
37
Locations
54.6
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pyoderma Gangrenosum (PG) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. The main objective of this study is to estimate the incidence proportion of all the infection reported as adverse drug reaction (ADR) of Humira with PG participants.

Humira is the only drug approved for the treatment of Pyoderma Gangrenosum (PG) in Japan. Approximately 60 adult participants with PG at approximately 60 sites in Japan.

Participants will receive injectable Humira (Adalimumab) as prescribed by the physician prior to enrolling in this study.

There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by verbal interview.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
    Actual Study Start Date :
    Feb 12, 2021
    Anticipated Primary Completion Date :
    Aug 31, 2025
    Anticipated Study Completion Date :
    Aug 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Participants Receiving Humira (Adalimumab)

    Participants receiving Adalimumab for Pyoderma Gangrenosum (PG).

    Outcome Measures

    Primary Outcome Measures

    1. Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR) [Up to 52 weeks]

      An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

    Secondary Outcome Measures

    1. Incidence Percentage of Serious Infection Reported as ADR [Up to 52 weeks]

      An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

    2. Incidence Percentage of each ADR (Besides Infection) [Up to 52 weeks]

      An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

    3. Change in Physician's Global Assessment (PGA) [Global] Grade [Up to Week 52]

      PGA will be used for overall assessment of efficacy.

    4. Change in PGA [Target] Grade [Up to Week 52]

      PGA will be used for assessment of efficacy of target lesions.

    5. Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing [Up to Week 52]

      IIA will be used for assessment of efficacy of target lesions.

    6. Change in Verbal Rating Scale (VRS) Category [Up to Week 52]

      Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain.

    7. Percentage of Participants with Recurrence [Up to Week 52]

      Recurrence of PG.

    8. Time to Recurrence (Day) [Up to Week 52]

      Recurrence of PG.

    9. Percentage of PG Subtype at Recurrence [Up to Week 52]

      Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).

    10. Pain Improvement Assessed with VRS [Week 26 to Week 52]

      Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with Pyoderma Gangrenosum (PG).

    • Have been prescribed Humira for PG treatment within 14 days.

    Exclusion Criteria:
    • Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya City University Hospital /ID# 233778 Nagoya shi Aichi Japan 467-8602
    2 NHO Nagoya Medical Center /ID# 246013 Nagoya-shi Aichi Japan 460-0001
    3 Akita University Hospital /ID# 242706 Akita-shi Akita Japan 010-8543
    4 Kyushu University Hospital /ID# 247492 Fukuoka-shi Fukuoka Japan 812-8582
    5 Japanese Red Cross Fukuoka Hospital /ID# 244051 Fukuoka-shi Fukuoka Japan 815-8555
    6 Kurume University Hospital /ID# 246502 Kurume-shi Fukuoka Japan 830-0011
    7 Central Japan International Medical Center /ID# 239391 Minokamo-shi Gifu Japan 505-8510
    8 Gunma University Hospital /ID# 239390 Maebashi-shi Gunma Japan 371-8511
    9 Sapporo Medical University Hospital /ID# 241180 Sapporo-shi Hokkaido Japan 060-8543
    10 Kansai Rosai Hospital /ID# 246592 Amagasaki-shi Hyogo Japan 660-8511
    11 Kobe University Hospital /ID# 249396 Kobe-shi Hyogo Japan 650-0017
    12 Nishi-Kobe Medical Center /ID# 244224 Kobe-shi Hyogo Japan 651-2273
    13 Ishikawa Prefectural Central Hospital /ID# 239089 Kanazawa-shi Ishikawa Japan 920-8530
    14 Kanazawa University Hospital /ID# 248730 Kanazawa-shi Ishikawa Japan 920-8641
    15 Takamatsu Red Cross Hospital /ID# 240576 Takamatsu-shi Kagawa Japan 760-0017
    16 Teikyo University Hospital, Mizonokuchi /ID# 244693 Kawasaki City Kanagawa Japan 213-0002
    17 Yokohama Municipal Citizen's Hospital /ID# 233779 Yokohama-shi Kanagawa Japan 221-0855
    18 Kumamoto University Hospital /ID# 244050 Kumamoto shi Kumamoto Japan 8608556
    19 Mie University Hospital /ID# 238747 Tsu-shi Mie Japan 514-8507
    20 Tohoku Medical and Pharmaceuti /ID# 230270 Sendai-shi Miyagi Japan 983-0005
    21 University of Miyazaki Hospital /ID# 241179 Miyazaki-shi Miyazaki Japan 889-1692
    22 Shinshu University Hospital /ID# 230272 Matsumoto-shi Nagano Japan 390-8621
    23 Nara Medical University Hospital /ID# 241880 Kashihara-shi Nara Japan 634-8522
    24 Okayama University Hospital /ID# 238746 Okayama-shi Okayama Japan 700-8558
    25 Naha City Hospital /ID# 240818 Naha-shi Okinawa Japan 902-8511
    26 Okinawa Kyodo Hospital /ID# 241739 那覇市 Okinawa Japan 900-0024
    27 Kansai Medical University Hospital /ID# 228783 Hirakata-shi Osaka Japan 573-1191
    28 Japanese Red Cross Osaka Hospital /ID# 228782 Osaka-shi Osaka Japan 543-8555
    29 Dokkyo Medical University Saitama Medical Center /ID# 248731 Koshigaya-shi Saitama Japan 343-8555
    30 Hamamatsu University Hospital /ID# 240817 Hamamatsu-shi Shizuoka Japan 431-3192
    31 Chutoen General Medical Center /ID# 228780 Kakegawa-shi Shizuoka Japan 436-0040
    32 Shizuoka Saiseikai Genaral Hospital /ID# 239088 Shizuoka-shi Shizuoka Japan 422-8527
    33 Teikyo University Hospital /ID# 239389 Itabashi-ku Tokyo Japan 173-8606
    34 Tokyo Medical University Hospital /ID# 233780 Shinjuku-ku Tokyo Japan 160-0023
    35 Yamanashi Kosei Hospital /ID# 242168 Yamanashi City Yamanashi Japan 405-0033
    36 Fukuchiyama City Hospital /ID# 246593 Fukuchiyama-shi Japan 620-8505
    37 Takatsuki General Hospital /ID# 244694 Osaka Japan

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04750213
    Other Study ID Numbers:
    • P20-251
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Pyoderma Gangrenosum
    Humira
    Adalimumab
    Additional relevant MeSH terms:
    Pyoderma
    Pyoderma Gangrenosum

    Study Results

    No Results Posted as of Jul 28, 2022